Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients

Fluid Overload Clinical Trial

Official title:

Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04215692
• Other study ID #: 2019-R-14
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: December 28, 2025

Study information

• Verified date: March 2024
• Source: Instituto Mexicano del Seguro Social
• Contact: Maricela García-Arellano, MD
• Phone: 449 994 6720
• Email: marigarcia8[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized clinical trial to evaluate the effect of using pulmonary ultrasound to guide fluid therapy on distinct variables.

Description:

In this randomized clinical trial, the investigators will evaluate the effect of guiding fluid therapy by pulmonary ultrasound on the following variables:

Length of stay in the pediatric ICU Duration of mechanical ventilation Oxygenation index PaO2/FiO2

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 28, 2025
• Est. primary completion date: December 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Week to 14 Years

Eligibility

Inclusion Criteria:

• All pediatric inpatient intensive care unit admissions

• Signed Informed Consent Form

Exclusion Criteria:

• Cyanotic congenital heart disease

• Not requiring mechanical ventilation

Related Conditions & MeSH terms

• Edema
• Fluid Overload
• Fluid Overload Pulmonary Edema
• Fluid Overload Without Edema
• Pneumonia, Ventilator-Associated
• Pulmonary Edema

Intervention

Diagnostic Test:
• Pulmonary ultrasound
Pulmonary ultrasound is a basic application of critical ultrasound, defined as a loop associating urgent diagnoses with immediate therapeutic decisions.

Locations

Country	Name	City	State
Mexico	Centenario Hospital Miguel Hidalgo	Aguascalientes

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social	Centenario Hospital Miguel Hidalgo

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay	Number of days that the patient requires care in the ICU	through study completion, an average of 14 days
Secondary	Oxygenation Index	Measure of the fraction of inspired oxygen (FiO2) and its usage within the body.	Daily through study completion, an average of 14 days
Secondary	PaO2/FIO2	Ratio of arterial oxygen partial pressure to fractional inspired oxygen	Daily through study completion, an average of 14 days
Secondary	Duration of mechanical ventilation	Days that a patient remains under mechanical ventilation	through study completion, an average of 14 days